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The Medicines (Products for Animal Use—Fees) Regulations 2004

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Site inspections

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8.—(1) Fees for inspections in connection with an application for the grant, variation or renewal of a manufacturer’s licence or for any other inspection in connection with such a licence shall be paid by the applicant or holder of the licence in accordance with Schedule 2 except as provided below.

(2) Where a manufacturing site in a non-EEA state is specified in a marketing authorisation or product licence or an application therefor and the site is inspected by the relevant authority, the marketing authorisation or product licence holder or applicant shall pay the relevant fee prescribed in Schedule 2; and if there is more than one marketing authorisation or product licence or application therefor in which the site in question is inspected, liability to pay the relevant fee prescribed in Schedule 2 shall be divided between the holders of or applicants for those marketing authorisations or product licences, as the case may be, in proportion to the number of marketing authorisations or product licences for products manufactured at that site held or applied for by each.

(3) No fee is payable in respect of any inspection of a site carried out within 6 months of a previous inspection in order to ascertain whether an alteration or improvement to that site, which was required in writing by the relevant authority as the result of that previous inspection, has been implemented.

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